Thomas Jefferson UniversitySidney Kimmel Medical College

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Phase III Study of an Investigational Medication as Adjunct Therapy in Subjects with Moderate-to-Severe Parkinson’s Disease

Our clinic is taking part in a global clinical research study to test an investigational medication when it is used together with levodopa (L-dopa).  We are looking for people with moderate-to-severe Parkinson’s disease to participate in this study.  You or someone you care for may be able to help.

 

This clinical research study will involve approximately 450 patients at 65 clinics around the world, including ours.

 

In order to participate in this study, patients must:

 

  • Be 30-85 years old
  • Have been taking levodopa (L-dopa) medication for Parkinson’s disease for 1 year or longer
  • Have been experiencing motor fluctuations (that is, medication effects wearing off prior to taking the next medication dose (“off” time)) for at least the last month, with or without jerky, dance-like movements of the arms and/or head (dyskinesia)

Our study staff will review additional study criteria at a study screening visit.

All participants will continue on L-dopa treatment during the study.  After an initial screening period of up to 4 weeks, qualified participants will be randomly assigned (by chance – like a flip of a coin) to the investigational medication or a placebo that looks like the investigational medication but does not contain the active ingredient.  This study medication will be taken in addition to the usual L-dopa medication.  Participants will continue on study treatment for 12 weeks.  During the study, participants will need to visit the clinic approximately 9 times. 

All study-related office visits, study-related evaluations, and study medications will be provided at no cost.

We encourage you to discuss study participation with your physician, family, and friends. While there is still no cure for Parkinson’s disease, participating in clinical trials can help researchers better understand and develop new treatments for this condition.

For more information contact:  Stephanie Sendek at Thomas Jefferson University: 215-955-8700 or Stephanie.Sendek@jefferson.edu